Under way, not recruiting
ROSA Knee System vs Conventional Total Knee Arthroplasty
NCT05685693 · Zuyderland Medisch Centrum · Updated 24 July 2024
- What is being tested
- Robotic-assisted total knee arthroplasty (raTKA); conventional total knee arthroplasty
- For
- Knee Osteoarthritis
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 40 years to 90 years. About 150 people. The full rules are on the registry page.
- Where
- Netherlands
- When
- Starts or started 16 Dec 2022, ends Dec 2035. Registered 17 Jan 2023.
- Results
- None posted yet.
In the researchers' words
This is a randomized clinical study, in which 150 patients with end-stage osteoarthritis will be enrolled to ROSA®-assisted knee arthroplasty or conventional knee arthroplasty. Patients are recruited at Zuyderland Medical Center, enrolled pre-operatively and followed up for 12 months post-surgery. In- and exclusion criteria are stated below. After recruitment, participants will be invited for a pre-operative visit. During this pre-operative visit Informed Consent is signed and completion of patient-reported outcome measures (PROMs) is checked. Additionally, measurements regarding body composition, strength and fitness and metabolic outcomes are performed. Participants will have a blood sample taken. Scans, adverse event and medication use will be confirmed. Participants will receive a ActiGraph for collecting data from physical activity. Of all patients, 72 will undergo additional measurements (gait, proprioception). During surgery ROSA- and surgery-data will be collected. Post-operative participants will have a 6-weeks, 3-month and 12-month visit. During these visits pre-operative measurements are repeated.
Sites
- Zuyderland Medical CenterSittard, Limburg, Netherlands
